Status:
COMPLETED
Transcranial Direct Current Stimulation (tDCS) in Human Subjects With PTSD Receiving an Exposure-based, Behavioral Therapy
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Post Traumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The primary objective of this study is to evaluate the safety, feasibility, and psychological and physiological treatment benefits of transcranial direct current stimulation (tDCS), a noninvasive brai...
Detailed Description
While the potential for non-invasive brain stimulation is exciting, research is needed to determine the safety, feasibility, and benefits of non-invasive brain stimulation in human subjects with PTSD....
Eligibility Criteria
Inclusion
- Individuals between the ages of 18 and 65 years old at time of screening.
- PTSD diagnosis as assessed by the Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
- Able to write, read, and speak English
Exclusion
- History of epilepsy or seizures.
- History of significant intracranial pathology (e.g., severe traumatic brain injury) or neurological disorder (e.g., Stroke, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Alzheimer's, Dementia, Parkinson's, and/or Huntington's).
- History of skin condition (e.g., eczema, psoriasis) where electrodes will be applied.
- Electronic implants in the body that could be susceptible to electrical current (e.g., cardiac pacemaker, cochlear implants, medical pump).
- Metallic objects other than dental appliances/fillings near the site of stimulation
- Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgement).
- Current moderate or severe substance use disorder.
- Suicidality and/or psychiatric risk requiring immediate intervention or a higher level of care than can be provided by the study treatment.
- Change in anticonvulsive or benzodiazepine medication regimen in the past month.
- History of adverse effects to previous tDCS or other brain stimulation technique.
- Concurrent engagement in another brain simulation technique or trauma-related psychotherapy for PTSD.
- Currently pregnant or breastfeeding.
Key Trial Info
Start Date :
January 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05419999
Start Date
January 9 2023
End Date
April 25 2024
Last Update
May 29 2025
Active Locations (1)
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1
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229